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2014-06-02

AstraZeneca: AstraZeneca welcomes positive data on the combination of olaparib and cediranib for the treatment of ovarian cancer patients

As part of the 50th Annual Meeting of the American Society for
Clinical Oncology (ASCO), Dr Joyce Liu today presented data
(http://www.cancer.gov/newscenter/newsfromnci/2014/OvarianNCT01116648ASCO)
on a Phase II study conducted by the American National Cancer
Institute (NCI), comparing the efficacy and tolerability of olaparib
and cediranib in combination to olaparib alone, for the treatment of
women with recurrent platinum-sensitive high-grade serous ovarian
cancer (abstract LBA5500). This is the first ovarian cancer study to
use a combination of investigational medicines that can be taken
orally.

Antoine Yver, Head of Oncology in AstraZeneca's Global Medicines
Development unit said: "The NCI data is extremely compelling, showing
that the combination of olaparib and cediranib nearly doubled the
progression-free survival benefit compared to olaparib alone. This
could offer real benefits to patients who currently have very limited
treatment options. At AstraZeneca we are committed to the rapid
development of our pipeline for ovarian cancer and we believe that
collaboration is an important component of this. We fully support the
NCI in their plans to conduct two late stage studies to further
investigate the combination. We also look forward to exploring the
Phase II data in more detail to inform our future development plans
for olaparib and cediranib."

Ovarian cancer is a serious, life-threatening disease and is the
seventh most commonly diagnosed cancer in women worldwide[1]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_edn1).
Historically, initial and late-stage treatment options for women
diagnosed with ovarian cancer have been limited and patients remain
heavily reliant on chemotherapy. Although recent advances are
providing new hope of improved outcomes, there remains significant
unmet medical need in this disease.

The NCI is currently planning to conduct two Phase III trials to
further investigate the combination of olaparib and cediranib in
ovarian cancer. Olaparib and cediranib are being investigated
individually in clinical trials for the treatment of patients with
this disease. Olaparib has already shown efficacy as a monotherapy[2]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_edn2)
and was recently granted Priority Review by the FDA for the treatment
of platinum sensitive relapsed ovarian cancer patients who have a
BRCA mutation. The EMA accepted a marketing authorisation application
for olaparib in September 2013.

In the Phase III ICON 6 trial, cediranib demonstrated significant
improvements in progression free survival and overall survival in
platinum sensitive relapsed ovarian cancer, when given during and
after chemotherapy, compared to chemotherapy alone. AstraZeneca has
consulted with regulatory agencies in the US and EU to understand how
the results of the ICON 6 study conducted by the UK Medical Research
Council (MRC) can best support a potential regulatory submission for
approval of cediranib in ovarian cancer. As a result of these
interactions, AstraZeneca is working with the MRC to conduct relevant
analyses of cediranib data with a view to potential regulatory
submissions later this year.

- ENDS -

NOTES TO EDITORS

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:
www.astrazeneca.com

CONTACTS

Media Enquiries

Esra Erkal-Paler +44 20 7604 8030 / +44 7771 740311 (UK/Global)

Ayesha Bharmal +44 20 7604 8034 / +44 7824 082209 (UK/Global)

Jacob Lund +46 8 553 260 20 (Sweden)

Investor Enquiries

Karl Hård +44 20 7604 8123  mob: +44 7789 654364

Colleen Proctor + 1 302 886 1842 mob: +1 302 357 4882

Anthony Brown +44 20 7604 8067 mob: +44 7585 404943

Jens Lindberg +44 20 7604 8414 mob: +44 7557 319729

----------------------------------------------------------------------

[1]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref1)
WHO Globocan 2012 Cancer Factsheet,
http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Accessed 22
May 2014.

[2]
(http://Scripts/lib/tiny_mce_3.4.5/plugins/paste/pasteword.htm#_ednref2)
Ledermann JA, et al. Olaparib maintenance therapy in
platinum-sensitive relapsed ovarian cancer. N Engl J Med
2012;366:1382-92.

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